The Effect of median Nerve Stimulation On cardiac electRophysiology (TENSOR)

Mortality, morbidity and health care costs due to atrial fibrillation (AF) are
worldwide growing problems and therapeutic interventions for AF are often not
effective. For many years, it has been suggested that the autonomic nervous
system (ANS) plays an important role in AF pathogenesis. The ANS may either
induce remodelling in the atria or undergo remodelling itself, thereby serving
as a substrate for AF. Several critical points within the cardiac neural axis
serve as targets for therapeutic intervention. Studies have demonstrated the
effectiveness of neuromodulation therapy for AF, including low-level vagus
nerve stimulation (LLVNS), stellate ganglion block, or ganglionated plexi
ablation, in reducing AF inducibility, incidence, and burden. Recently, median
nerve stimulation (MNS) has also been found to have antiarrhythmic effects.
There is evidence that MNS prevents atrial effective refractory period (AERP)
shortening and increased AF inducibility during rapid atrial pacing. A wearable
device has been designed for MNS, and preliminary data within the AF population
indicate the potential of this device in treating AF.
Previous mapping study indicates that LLVNS affects electrophysiological
properties during sinus rhythm (SR). However, the underlying
electrophysiological mechanism is unknown.

The primary objective of this pilot study is to examine the impact of MNS on
cardiac electrophysiology measured at a high-resolution scale during SR.

This pilot study is designed as an interventional study.

High-resolution cardiac mapping during SR

Neither the patient, nor the investigators are in any way compensated for their
participation with regards to this study. The risks associated with
participation are known to be negligible, since epicardial mapping using the
non-investigational product (see Medical Device Dossier) in over 1500 patients
in previous METC-approved studies (MEC 2010-054, MEC 2014-393, MEC 2015-373,
MEC 2019-543, MEC 2020-0124) did not cause any complications. The duration of
the surgical procedure is minimally prolonged by the epicardial mapping
procedure with an estimate of 8-10 minutes.
Studies in different medical fields have shown that MNS is a safe treatment
modality. Patients may benefit from this study as MNS has been shown to prevent
AERP shortening and increased AF inducibility during rapid atrial pacing.
Moreover, this novel therapy may serve as a treatment of AF in non-surgical
patients. At the same time, the device's wearable nature and monitoring
capabilities have emerged as key advantages for patients, facilitating
treatment and enabling adjustments to care plans.